16 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ISS-JAZZ Screw System and JAZZ CAP SP
FDA 510(k)
FDA Class 2
·Orthopedic
Oticon
FDA UDI
Oticon A/S·05707131331595·OPN 3, KIT 13 2.4G NFM R C001
PROTRON TECHNOLOGIES, LLC STETHOTRON
FDA 510(k)
FDA Class 2
·Cardiovascular
BIOPSY HANDY, MRI BIOPSY HANDY
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code OYC·June 21, 2013
LIGAMAX 5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code FZP·October 3, 2008
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·July 28, 2011
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Injury
·COOK INC·Product code KRA·April 27, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·April 11, 2022
MULTI-SIDEPORT DUAL CHECK VALVE CATHETER INFUSION SET
FDA Adverse Event
Malfunction
·COOK INC·Product code KRA·August 19, 2022
Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Component: N/A
FDA Enforcement
Class II
·Ongoing·Sterilmed, Inc.·November 26, 2025
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·March 24, 2016
BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
FDA Adverse Event
Malfunction
·SORIN GROUP ITALIA·Product code DTN·July 25, 2018
Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024